| . | Placebo (N = 18) . | Metformin (N = 19) . |
|---|---|---|
| Total no. of adverse events reported | 12 | 8 |
| Total no. of serious adverse events reported | 2 | 1 |
| Total no. of hospitalizations | 4 | 3 |
| Proportion reporting at least one adverse event, no. [% (95% CI)] | 7 [39 (14–64)] | 8 [42 (18–67)] |
| Proportion reporting at least one serious adverse event, no. [% (95% CI)] | 1 [6 (<1–17)] | 1 [5 (<1–16)] |
| Proportion with adverse event related to treatment, no. [% (95% CI)] | 3 [17 (<1–36)] | 3 [16 (<1–34)] |
| Severe hypoglycemia | ||
| Subjects with at least one event, no. [% (95% CI)] | 0 | 0 |
| Diabetic ketoacidosis | ||
| Subjects with at least one event, no. [% (95% CI)] | 0 | 1 [5 (<1–16)] |
| Gastrointestinal events | ||
| Subjects with at least one event, no. [% (95% CI)] | 5 [28 (5–51)] | 5 [26 (5–48)] |
| Liver enzymes, % (95% CI) | ||
| ALT, % >1.5-fold upper limit of normal | 0 | 0 |
| Serum creatinine, % (95% CI) | ||
| Proportion above upper limit of normal | 0 | 0 |
| Lactic acidosis, % (95% CI) | ||
| Proportion with detected lactic acidosis | 0 | 0 |
| . | Placebo (N = 18) . | Metformin (N = 19) . |
|---|---|---|
| Total no. of adverse events reported | 12 | 8 |
| Total no. of serious adverse events reported | 2 | 1 |
| Total no. of hospitalizations | 4 | 3 |
| Proportion reporting at least one adverse event, no. [% (95% CI)] | 7 [39 (14–64)] | 8 [42 (18–67)] |
| Proportion reporting at least one serious adverse event, no. [% (95% CI)] | 1 [6 (<1–17)] | 1 [5 (<1–16)] |
| Proportion with adverse event related to treatment, no. [% (95% CI)] | 3 [17 (<1–36)] | 3 [16 (<1–34)] |
| Severe hypoglycemia | ||
| Subjects with at least one event, no. [% (95% CI)] | 0 | 0 |
| Diabetic ketoacidosis | ||
| Subjects with at least one event, no. [% (95% CI)] | 0 | 1 [5 (<1–16)] |
| Gastrointestinal events | ||
| Subjects with at least one event, no. [% (95% CI)] | 5 [28 (5–51)] | 5 [26 (5–48)] |
| Liver enzymes, % (95% CI) | ||
| ALT, % >1.5-fold upper limit of normal | 0 | 0 |
| Serum creatinine, % (95% CI) | ||
| Proportion above upper limit of normal | 0 | 0 |
| Lactic acidosis, % (95% CI) | ||
| Proportion with detected lactic acidosis | 0 | 0 |
| . | Placebo (N = 18) . | Metformin (N = 19) . |
|---|---|---|
| Total no. of adverse events reported | 12 | 8 |
| Total no. of serious adverse events reported | 2 | 1 |
| Total no. of hospitalizations | 4 | 3 |
| Proportion reporting at least one adverse event, no. [% (95% CI)] | 7 [39 (14–64)] | 8 [42 (18–67)] |
| Proportion reporting at least one serious adverse event, no. [% (95% CI)] | 1 [6 (<1–17)] | 1 [5 (<1–16)] |
| Proportion with adverse event related to treatment, no. [% (95% CI)] | 3 [17 (<1–36)] | 3 [16 (<1–34)] |
| Severe hypoglycemia | ||
| Subjects with at least one event, no. [% (95% CI)] | 0 | 0 |
| Diabetic ketoacidosis | ||
| Subjects with at least one event, no. [% (95% CI)] | 0 | 1 [5 (<1–16)] |
| Gastrointestinal events | ||
| Subjects with at least one event, no. [% (95% CI)] | 5 [28 (5–51)] | 5 [26 (5–48)] |
| Liver enzymes, % (95% CI) | ||
| ALT, % >1.5-fold upper limit of normal | 0 | 0 |
| Serum creatinine, % (95% CI) | ||
| Proportion above upper limit of normal | 0 | 0 |
| Lactic acidosis, % (95% CI) | ||
| Proportion with detected lactic acidosis | 0 | 0 |
| . | Placebo (N = 18) . | Metformin (N = 19) . |
|---|---|---|
| Total no. of adverse events reported | 12 | 8 |
| Total no. of serious adverse events reported | 2 | 1 |
| Total no. of hospitalizations | 4 | 3 |
| Proportion reporting at least one adverse event, no. [% (95% CI)] | 7 [39 (14–64)] | 8 [42 (18–67)] |
| Proportion reporting at least one serious adverse event, no. [% (95% CI)] | 1 [6 (<1–17)] | 1 [5 (<1–16)] |
| Proportion with adverse event related to treatment, no. [% (95% CI)] | 3 [17 (<1–36)] | 3 [16 (<1–34)] |
| Severe hypoglycemia | ||
| Subjects with at least one event, no. [% (95% CI)] | 0 | 0 |
| Diabetic ketoacidosis | ||
| Subjects with at least one event, no. [% (95% CI)] | 0 | 1 [5 (<1–16)] |
| Gastrointestinal events | ||
| Subjects with at least one event, no. [% (95% CI)] | 5 [28 (5–51)] | 5 [26 (5–48)] |
| Liver enzymes, % (95% CI) | ||
| ALT, % >1.5-fold upper limit of normal | 0 | 0 |
| Serum creatinine, % (95% CI) | ||
| Proportion above upper limit of normal | 0 | 0 |
| Lactic acidosis, % (95% CI) | ||
| Proportion with detected lactic acidosis | 0 | 0 |
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